BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER KNEE IMPLANT

    MDR report key: 2100548 · Received May 17, 2011

    Report

    Report Number
    1822565-2011-01182
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    May 23, 2009
    Report Date
    April 18, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE PRIMARY OPERATIVE NOTES DO NOT INDICATE ANYTHING OUT OF THE ORDINARY. THE REVISION OPERATIVE NOTES INDICATE THAT THE TIBIAL COMPONENT WAS LOOSE AND WAS ABLE TO BE REMOVED WITHOUT ANY BONE LOSS. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. WITH THE INFO PROVIDED A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, THE COMPLAINT MAYBE REVISED UPON RETURN OF X-RAYS AND/OR PRODUCT OR FURTHER INFO. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT EXPERIENCED KNEE PAIN AND LOOSENING, AND WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER KNEE IMPLANT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention